Cleared Traditional

K231625 - VitalDetect

K231625 is an FDA 510(k) clearance for VitalDetect, manufactured by Wellvii, Inc.. The device is a Class 2 Cardiovascular device with product code FLL cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K231625 · Wellvii, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
245d
Days
Class 2
Risk

K231625 is an FDA 510(k) clearance for the VitalDetect. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Wellvii, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on February 2, 2024 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Wellvii, Inc. devices

FDA 510(k) Submission Details - K231625

510(k) Number K231625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date February 02, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 374
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K231625.
Digital Thermometer
K230889 · Wenzhou Yosun Medical Technology Co.,Ltd · Apr 2024
Probe Covers (YF-001, YF-002)
K240023 · Shenzhen YI Fang Blister Packaging Co., Ltd. · Mar 2024
Infrared Thermometer: Model YJ600
K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · Feb 2024
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
K232338 · Alicn Medical (Shenzhen), Inc. · Dec 2023
THERMOCLICK
K222057 · T&R BIOFAB CO., Ltd. · Dec 2023